1. Field of the Invention
The present invention generally relates to physiological monitoring devices. More particularly, this invention relates to two or more site-specific recorders and the method for monitoring, recording and analyzing the medical disorders of a fully ambulatory subject.
2. Description of the Related Art
The diagnosis of sleep disorders often involves polysomnopgraphy (PSG), the monitoring and recording over an extended period of time of the temporal variations in the amplitude of the patient's sleep-impacted, physiological parameters, including: heart rate, eye blink activity, airflow rate, thorax and abdomen respiration rates, the blood's oxygen saturation level, electroencephalograms (EEG), electrooculorgrams (EOG), and electromyograms (EMG). Such intensive monitoring activities are typically conducted in clinical settings by trained PSG technicians who utilize expensive monitoring equipment having multiple sensors that are tethered to a centralized recording system and power supply.
For several decades, the recordings of such physiological parameters were provided by strip chart recorders that produced long strips of paper with ink markings that displayed the varying physiological parameters. The clinician would then examine such records and "score" each abnormal sleep event that occurred. This practice continues today with the clinician now viewing computer screens displaying the varying physiological parameters.
More recently, a number of portable recording systems for screening and diagnosing sleep disorders have been marketed. These systems range from multi-channel, PSG-style systems to much simpler units that monitor only one or more of the possible physiological parameters of interest. However, these multi-channel, portable systems remain technically complex, expensive and usually require trained PSG technicians to supervise their use. The complexity of the tethered sensors and electrode wires that are used with these multi-channel, portable systems is shown in FIG. 1.
Some of the newer of these portable systems offer comprehensive software for display and analysis of the collected sleep data, and some offer automatic sleep event scoring. However, such scoring has been found to have varying degrees of reliability due to the technical problems associated with assuring good signal fidelity in the monitored parameters. Thus, all of these systems recommend for accurate identification of abnormal sleep events that the data be interpreted and evaluated by experienced clinicians or trained PSG technicians.
The nature of PSG signal fidelity problems is seen in FIG. 2 which shows the tracings provided by the manufacturer of the portable system shown in FIG. 1 for the temporal variations in airflow and respiration sensors located respectively at the patient's (1) mouth and nasal passageway, (2) chest, and (3) abdomen. Both the chest and abdomen sensors show poor signal fidelity and the abdomen signal is amplitude clipped and distorted. The two respiration signals are time shifted about five percent, while the airflow signal is shifted about fifteen percent.
Since PSG scoring is largely subjective, experienced scorers can generally interpret with good accuracy the action and interactions of poorly shaped and time skewed signals. Although these distortions are commonly accepted as normal for manual scoring, such poor fidelity signals would be unsatisfactory for automated or computer-based scoring.
All of the current, portable sleep testing systems share common, less-than-desirable features for home use: (1) they are bedside portable, but their size and weight does not allow the patient to be ambulatory, which can be essential for diagnosing patients problems such as excessive sleepiness, (2) they are not designed for unattended use--a technician must come to the home for set-up, disconnection and data retrieval, (3) patients must be outfitted with an array of tethered electrode wires and sensors for connection to bulky body monitors or table-top consoles, and (4) most require subjective analysis of the data by highly trained, sleep professionals.
Recognizing the need for an improved apparatus or method for diagnosing of the various medical conditions of a fully ambulatory subject who exhibits temporal variations in various physiological parameters as a result of this medical condition, it is therefore a general object of the present invention to provide a novel method and ambulatory, distributed recorders system to meet such needs.